Apparatus for implanting a prothesis within a body passageway

ABSTRACT

An apparatus for repairing a body passageway, includes a catheter having first and second inflatable portions, a prosthesis having first and second ends, and a first securing member associated with the first end of the prosthesis and disposed on the second inflatable portion of the catheter. A method of assembling the apparatus for repairing a body passageway, a method of repairing a body passageway, and a method for implanting a prosthesis are also described.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to an apparatus and method for implanting aprosthesis in a body passageway, a method for repairing a bodypassageway and a method for assembling an apparatus for repairing a bodypassageway.

2. Description of the Prior Art

Various types of surgical procedures for repairing or reinforcing bodypassageways require the use of catheters. It is well known thatcatheters, having inflatable portions, or balloons, are used to implantprosthesis, or grafts, in arteries, ureters and other body passageways.For such implantations, the inflatable portion of a catheter may be usedto expand and deform a first attachment device, or securing means,disposed about the balloon and associated with the first end of theprosthesis, by subjecting the attachment device, or securing means, toexpansion forces by inflation of the balloon. Upon deflation of theballoon, the first attachment device and prosthesis remain securedwithin the body passageway. The catheter is then removed from the bodypassageway and a second attachment device may be placed about thecatheter balloon. The catheter is reintroduced into the body passagewayfor securing the second end of the prosthesis to the body passagewaywith the second attachment device. Alternatively, a second catheter witha second attachment device is introduced. Upon removal of the catheterfrom the body passageway, the first and second attachment devices, orsecuring means, and prosthesis remain anchored to the internal wall ofthe body passageway. A disadvantage of the prior art techniques is thenecessary surgery time for twice inserting a catheter to secure theprosthesis within the body passageway.

The use of catheters with two inflatable balloons for implanting aprosthesis is also known in the prior art. Typically, an attachmentdevice, or securing means, is associated with each end of the prosthesisand is disposed about each catheter balloon for placement within thebody passageway. The first, or upstream, end of the prosthesis and firstattachment device are disposed about the distal, or outermost, balloon,while the second, or downstream, end of the prosthesis and secondattachment device are associated with the proximal balloon. Thecatheter, prosthesis and attachment devices are introduced into the bodypassageway and the balloons are expanded to secure the attachmentdevices and prosthesis within the body passageway.

A potential disadvantage of prior art multi-balloon catheters is thatthe prosthesis may be implanted without being urged across its entirelength toward the interior wall surface of the body passageway to removeor reduce kinking, twisting and/or folding of the prosthesis to ensure aclear, open passageway through the prosthesis within the bodypassageway. Another potential disadvantage of the prior art devices isthat the second attachment device, or securing means, cannot beselectively positioned at any location within the prosthesis after thefirst attachment device, or securing means, and first end of theprosthesis have been secured within the body passageway.

Accordingly, prior to the development of the present invention, therehas been no apparatus for repairing a body passageway, method ofassembling such an apparatus, method of repairing a body passageway andmethod of implanting a prosthesis within a body passageway with the useof such an apparatus, which: allows for the prosthesis to be urgedacross its entire length toward the interior wall surface of the bodypassageway to remove or reduce kinking, twisting and/or folding of theprosthesis to ensure a clear, open passageway through the prosthesiswithin the body passageway; and allows for the second attachment device,or securing means, to be selectively positioned at any location withinthe prosthesis after the first attachment device, or securing means, andfirst end of the prosthesis have been secured within the bodypassageway. Therefore, the art has sought an apparatus for repairing abody passageway, method of assembling such an apparatus, method ofrepairing a body passageway and method of implanting a prosthesis withina body passageway with the use of such an apparatus, which: is believedto allow for the prosthesis to be urged across its entire length towardthe interior wall surface of the body passageway to remove or reducekinking, twisting and/or folding of the prosthesis to ensure a clear,open passageway through the prosthesis within the body passageway; andis believed to allow for the second attachment device, or securingmeans, to be selectively positioned at any location within theprosthesis after the first attachment device, or securing means, andfirst end of the prosthesis have been secured within the bodypassageway.

SUMMARY OF THE INVENTION

In accordance with the invention, the foregoing advantages have beenachieved through the present method and apparatus for implanting aprosthesis within a body passageway. The apparatus of the presentinvention may include: a catheter having first and second ends, thefirst end of the catheter being insertable into the body passageway, afirst inflatable portion disposed on the catheter proximate the firstend of the catheter, and a second inflatable portion disposed on thecatheter between the first inflatable portion and the second end of thecatheter; a prosthesis having first and second ends; and a first meansfor securing the prosthesis to the body passageway, the first securingmeans being associated with the prosthesis proximate the first end ofthe prosthesis, and the first securing means and prosthesis beingdisposed upon the second inflatable portion of the catheter. A furtherfeature of the present invention is that the first and second inflatableportions may be first and second inflatable balloons.

Further features of the present invention may include: the inclusion ofa second means for securing the prosthesis to the body passagewaydisposed upon the first inflatable member; and the first and secondmeans for securing being first and second expandable tubular shapedmembers.

In accordance with the invention, the foregoing advantages have alsobeen achieved through the present method of assembling an apparatus,having a catheter with first and second inflatable members, and aprosthesis, for repairing a body passageway. The method of the presentinvention may include the steps of: associating a first means forsecuring, the prosthesis within the body passageway, with theprosthesis, proximate the first end of the prosthesis; disposing thefirst securing means and the first end of the prosthesis about thesecond inflatable member of the catheter; and disposing a second meansfor securing the prosthesis within the body passageway about the firstinflatable member of the prosthesis. A further feature of the presentinvention may include the step of providing a delivery sheath about thecatheter, prosthesis and the first and second securing means.

In accordance with the invention the foregoing advantages have also beenachieved through the present method of repairing a body passagewayhaving an interior wall surface with an elongate, tubular shapedprosthesis and a catheter having first and second ends, a firstinflatable member disposed on the catheter proximate the first end ofthe catheter, a second inflatable member disposed on the catheterbetween the first inflatable member and the second end of the catheter.The method of the present invention may include the steps of: providinga first means, for securing the prosthesis within the body passageway tothe prosthesis, proximate the first end of the prosthesis; providing thefirst securing means and the first end of the prosthesis about thesecond inflatable member; introducing the catheter, having the firstsecuring means and prosthesis disposed thereon, into the bodypassageway; positioning the second inflatable member of the catheter ata desired location within the body passageway; securing the firstsecuring means and the prosthesis within the body passageway byinflating the second inflatable member; deflating the second inflatablemember; and removing the catheter from the body passageway.

A further feature of the present invention may include the steps of atleast partially deflating the second inflatable member and moving thesecond inflatable member from the first end toward the second end of theprosthesis, to urge the prosthesis toward the interior wall surface ofthe body passageway. A further feature of the present invention mayinclude the steps of: disposing a second securing means upon the firstinflatable member; selectively positioning the first inflatable memberwithin the prosthesis while the prosthesis is located in the bodypassageway; and securing the second securing means and the prosthesiswithin the body passageway by inflating the first inflatable member.

Another aspect of the present invention is a method of implanting,within a body passageway, a prosthesis, having first and second ends,the first end of the prosthesis being associated with a first securingmeans, by use of a catheter, the catheter having first and second ends,a longitudinal axis extending therebetween, and first and secondinflatable portions, the first inflatable portion being disposedproximate the first end of the catheter, the second inflatable portionbeing disposed between the first inflatable portion and the second endof the catheter, the first end of the prosthesis and the first securingmeans being disposed on the second inflatable portion of the catheter,and a second securing means being disposed upon the first inflatableportion of the catheter. The method of the present invention may includethe steps of: delivering the catheter, the prosthesis and the first andsecond securing means into the body passageway; inflating the secondinflatable portion of the catheter to expand the first securing meansand to anchor the first securing means and first end of the prosthesiswithin the body passageway; at least partially deflating the secondinflatable portion of the catheter; moving the second inflatable portionthrough the prosthesis; positioning the first inflatable portion at adesired location at least partially within the prosthesis; inflating thefirst inflatable portion to expand the second securing means, andanchoring the second securing means and the prosthesis within the bodypassageway; deflating the first inflatable portion; and removing thecatheter from the body passageway. A further feature of the presentinvention may include the step of utilizing, as the first and secondsecuring means, first and second expandable tubular shaped members.

The methods and apparatus for repairing a body passageway of the presentinvention, when compared with previously proposed prior art devices andmethods for repairing body passageways, are believed to have theadvantages of: allowing the prosthesis to be urged across its entirelength toward the interior wall surface of the body passageway to removeor reduce kinking, twisting and/or folding of the prosthesis to ensure aclear, open passageway through the prosthesis within the bodypassageway; allowing the second attachment device, or securing means, tobe selectively positioned at any location within the prosthesis afterthe first attachment device, or securing means, and first end of theprosthesis have been secured within the body passageway.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a partial cross-sectional view of the apparatus of the presentinvention disposed in a body passageway;

FIG. 2 is a partial cross-sectional view of the apparatus of the presentinvention within a body passageway, illustrating a second inflatableportion of a catheter in an inflated configuration;

FIG. 3 is a partial cross-sectional view of an apparatus of the presentinvention within a body passageway after a first securing means and thefirst end of a prosthesis are secured within the body passageway;

FIG. 4 is a cross-sectional view of the apparatus of the presentinvention, within a body passageway, having a second inflatable portionin its expanded configuration;

FIG. 5 is a partial cross-sectional view of the apparatus of the presentinvention within a body passageway after a prosthesis has been implantedin the body passageway;

FIG. 6 is a partial cross-sectional view of an abdominal aortic aneurysmin the process of being repaired in accordance with the presentinvention; and

FIG. 7 is a partial cross-sectional view of the abdominal aorticaneurysm of FIG. 6, illustrating a prosthesis and securing meansanchored in the body passageway in accordance with the presentinvention.

While the invention will be described in connection with the preferredembodiment, it will be understood that it is not intended to limit theinvention to that embodiment. On the contrary, it is intended to coverall alternatives, modifications, and equivalents, as may be includedwithin the spirit and scope of the invention as defined by the appendedclaims.

DETAILED DESCRIPTION OF THE INVENTION

In FIGS. 1-6, an apparatus 150 for repairing a body passageway 152, suchas an artery (153, FIGS. 6-7) or ureter, is shown. Generally, theapparatus 150 includes: a catheter 160 having at least two inflatableportions 170, 180; a prosthesis, or graft, 200; and means for securing250 the prosthesis, or graft, 200 within the body passageway 152.

The catheter 160 of the present invention may be any known type ofintraluminally deliverable catheter having at least two inflatableportions, such as the balloon device disclosed in U.S. Pat. No.5,219,355 issued on Jun. 15, 1993, to Juan C. Parodi and Hector D.Barone, incorporated herein by reference. With reference to FIG. 1, thecatheter 160 includes first and second ends 164, 166, respectively, anda longitudinal axis 168 extending therebetween, the first end 164 beinginsertable into the body passageway 152.

For purposes of illustration, catheter 160 is shown in FIGS. 1-5 toinclude first and second inflatable portions 170, 180 disposed on thecatheter 150 along its longitudinal axis 168 (FIG. 1), although there isno limit as to the number of inflatable portions that may be included onthe catheter in the present invention. The first inflatable portion 170of the catheter 160 is disposed on the catheter 160 proximate the firstend 164 of the catheter 160, while the second inflatable portion 180 isdisposed on the catheter 160 between the first inflatable portion 170and the second end 166 of the catheter 160. The inflatable portions 170,180 may be any known type of inflatable devices used in connection withcatheters and capable of being inflated and deflated while locatedwithin a body passageway, such as balloons 172, 182 (FIG. 2).

With further reference to FIGS. 1-2, the apparatus 150 may include aprosthesis, or graft, 200 for delivery to the body passageway 152, and ameans for securing 250 the prosthesis 200 within the body passageway152. The prosthesis, or graft, 200 has first and second ends 204, 206and a wall surface 208 disposed therebetween, the prosthesis, or graft,200 adapted to be disposed within the body passageway 152, such as thetubular graft described in U.S. Pat. No. 5,360,443, issued on Nov. 1,1994 to Hector D. Barone, Julio C. Palmaz and Juan C. Parodi, which isincorporated herein by reference.

In the preferred embodiment of FIGS. 1-2, the means for securing 250 theprosthesis, or graft, 200 within the body passageway includes first andsecond securing means 270, 280. First and second securing means 270, 280may each be at least one expandable tubular shaped member 272, 282. Anyknown type of intraluminally deliverable expandable member, or stent,could be utilized as first and second securing means 270, 280, providedit has the ability to be secured to a prosthesis, carried on aninflatable member of a catheter for delivery into a body passageway andexpanded to secure the expandable member and prosthesis to the interiorwall of a body passageway. An example of an expandable tubular shapedmember suitable for use in the present invention is shown in U.S. Pat.No. 4,773,665, issued Mar. 29, 1998 to Julio C. Palmaz and incorporatedherein by reference.

As shown in FIGS. 1 and 2, first securing means 270 is preferablyassociated with the first end 204 of the prosthesis 200 and releasablymounted upon the second inflatable member 180 for delivery into the bodypassageway 152. The first securing means 270 and first end 204 of theprosthesis 200 may be associated in any suitable manner, such as withsmall sutures. After the first securing means 270 and first end 204 ofthe prosthesis 200 are disposed on the second inflatable member 180, thesecond end 206 of the prosthesis 200 will extend over the catheter 160in the direction of the second end 166 of the catheter 160. The secondsecuring means 280 may be releasably mounted upon the first inflatablemember 170 for delivery to the body passageway 152 and for furthersecuring the prosthesis 200 within the body passageway 152, as will behereinafter described in further detail. Each of the first and secondsecuring means 270, 280 may be disposed upon the inflatable members 170,180 in any suitable fashion, whereby upon inflation of the respectiveinflatable members, the associated securing means and prosthesis areforced radially outwardly into contact with the interior wall 154 of thebody passageway 152. A delivery sheath 290 (FIG. 1) may be providedabout the catheter 160, the prosthesis 200 and the first and secondsecuring means 270, 280 for delivery into the body passageway 152.

With further reference to FIG. 1, a method of assembling the apparatus150, as described above, for repairing a body passageway 152 is shown.The apparatus 150 includes a catheter 160 having at least two inflatableportions 170, 180, a prosthesis 200, and first and second means forsecuring 270, 280 the catheter 160 within the body passageway 152. Themethod of assembling includes the step of associating the first securingmeans 270 with the prosthesis 200 proximate the first end 204 of theprosthesis 200. The first securing means 270 and first end 204 of theprosthesis 200 may be associated in any suitable manner, such as withsmall sutures. The first securing means 270 and first end 204 of theprosthesis 200 are then disposed upon the second inflatable member 180of the catheter 160, so that the prosthesis 200 extends over thecatheter 160 in the direction of the second end 166 of the catheter 160.The second means for securing 280 the prosthesis 200 within the bodypassageway 152 is disposed upon the first inflatable member 170. Each ofthe first and second securing means 270, 280 may be disposed upon theinflatable members 170, 180 in any suitable manner, whereby uponinflation of the respective inflatable members, the associated securingmeans and prosthesis are forced radially outwardly into contact with theinterior wall 154 of the body passageway 152. The method of assemblingmay include the further step of providing a conventional delivery sheath290 about the catheter 160, prosthesis 200 and securing means 250, whichis removed as the catheter 160 is disposed within the body passageway152.

With reference to FIGS. 1-3, a method of repairing a body passageway152, having an interior wall surface 154, with an elongate, tubularshaped prosthesis 200 and a catheter 160 is shown. The catheter 160, asdescribed above, has first and second ends 164, 166, a first inflatablemember 170 disposed on the catheter proximate the first end 164 of thecatheter 160, and a second inflatable member 180 disposed on thecatheter 160 between the first inflatable member 170 and the second end166 of the catheter 160.

A first means 270 for securing the prosthesis 200 within the bodypassageway 152, as described above, is provided proximate the first end204 of the prosthesis 200. The first securing means 270 and the firstend 204 of the prosthesis 200 are provided disposed upon the secondinflatable member 180 of the catheter 160. The catheter 160, having thefirst securing means 270 and prosthesis 200 disposed thereon, isintroduced into the body passageway 152 and selectively positionedtherein, using conventional techniques. By first inflating the secondinflatable member 180, the first securing means 270 may be expanded tosecure the first securing means 270 and prosthesis 280 within the bodypassageway (FIG. 2).

As shown in FIG. 3, the method of repairing a body passageway 152 mayinclude the further step of at least partially deflating the secondinflatable member 280 and moving the second inflatable member 280 in thedirection of arrow 289 from the first end 204 toward the second end 206of the prosthesis 200 to urge the prosthesis 200 toward the interiorwall surface 154 of the body passageway 152. As a result, any kinking,twisting and/or folding in the prosthesis 200 will be removed orreduced, enhancing the fit of the prosthesis 200 within the bodypassageway 152 and optimizing the effect of the prosthesis 200 as afluid passageway (189 FIG. 5) within the body passageway 152.

The method of repairing a body passageway 152 may also include the stepof disposing a second securing means 280 upon the first inflatablemember 170 (FIGS. 1-3) prior to the introduction the catheter 160 withinthe body passageway 152. As shown in FIG. 3, after the catheter 160 isintroduced into the body passageway 152 and the first securing means 270and first end 204 of the prosthesis 200 are secured within the bodypassageway 152, the catheter 160 may be moved to selectively positionthe first inflatable member 170 and second securing means 280 within theprosthesis 200. The second securing means 280 may be expanded (FIG. 4)to secure the second securing means 280 and the prosthesis 200 withinthe body passageway 152 by inflating the first inflatable member 170.The first inflatable member 170 may then be deflated, and the catheter160 may be removed from the body passageway 152 (FIG. 5). After thefirst and second securing means 270, 280 and prosthesis 200 are releasedfrom the catheter 160, the prosthesis 200 provides a passageway 189(FIG. 5) through the body passageway 152 so that the body fluid flowingthrough the body passageway 152 can pass through the prosthesis 200.

A method of implanting a prosthesis 200, having first and second ends204, 206, within a body passageway 152 (FIGS. 1-5), at a location ofrepair, such as an arterial aneurysm 292 (FIGS. 6-7), with an apparatus150 will be described. As shown in FIG. 1, a first securing means 270 isassociated with the first end 204 of the prosthesis 200, and the firstsecuring means 270 and first end 204 of the prosthesis 200 are disposedon a second inflatable portion 180 of a catheter 160 of the apparatus150. A second securing means 280 is disposed on a first inflatableportion 170 of the catheter 160. First and second expandable tubularshaped members 272, 282 (FIGS. 1 and 2) may be utilized as first andsecond securing means 270, 280. A conventional delivery sheath 290(FIG. 1) may be provided about the catheter 160, the prosthesis 200 andthe first and second securing means 270, 280 for delivery into the bodypassageway 152. The catheter 160, as illustrated in FIG. 1, is in theconfiguration it would have for intraluminal delivery.

The catheter 160, prosthesis 200 and first and second securing means270, 280 are delivered, in a conventional manner, into the bodypassageway 152, and selectively positioned proximate a desired area ofimplantation of the prosthesis 200, such as aneurism 292 (FIGS. 6-7).The catheter sheath 290, if included, is removed in a conventionalmanner. As shown in FIG. 2, the second inflatable portion 180 of thecatheter 160 is inflated to expand the first securing means 270, andanchor the first securing means 270 and first end 204 of the prosthesis200 within the body passageway 152 at a desired location. Further, thesecond inflatable member 180 may be at least partially deflated, and thecatheter 160 moved within the body passageway 152 so that the secondinflatable portion 180 moves through the prosthesis 200 from the firstend 204 to the second end 206 of the prosthesis 200 to remove or reducekinks, twist or folds in the prosthesis 200 (FIG. 3).

As shown in FIG. 3, after the first securing means 270 and first end 204of the prosthesis 200 are disposed within the body passageway 152, thecatheter 160 may be moved to selectively position the first inflatableportion 170 and second securing means 280 at a desired location at leastpartially within the prosthesis 200. The first inflatable portion 170may be inflated (FIGS. 4 and 6) to expand the second securing means 280and secure the second securing means 280 and prosthesis 200 within thebody passageway 152. The first inflatable portion 170 of the catheter160 may then be deflated and the catheter 160 removed from the bodypassageway 152, as shown in FIG. 5.

FIGS. 6 and 7 illustrate the use of the apparatus 150 and methods of thepresent invention to repair an abdominal aortic aneurism 292 in an aorta291. The apparatus 150 could also be utilized in the thoracic aorta, andcan be used to repair thoracic aneurysms or thoracic dissectinganeurysms. Accordingly, use of the term "aortic aneurism" in thisspecification is intended to relate to and mean both abdominal aorticaneurysms and thoracic aneurysms. As shown, the areas of thrombosis 294is disposed against the interior wall surface 296 of the aorta 291.Associated with the aorta 291, above aneurism 292, are a plurality ofrenal arteries, 298 in fluid communication with aorta 291. Blood flowsthrough the aorta 291 in the direction of arrow 299. The prosthesis 200provides a passageway 300 through the abdominal aortic, or arterial,aneurysm, 292, so that blood can pass through the aneurysm 292 and beseparated therefrom. As seen in FIG. 6, the existing aortic wall 296 andthe thrombosis 294 may provide additional support and reinforcement forthe prosthesis 200.

The apparatus 150 of the present invention and methods for assemblingthe apparatus 150, repairing a body passageway 152 and implanting aprosthesis 200 in the body passageway 152 are believed to be useful torepair or reinforce numerous types of body passageways 152 includingabdominal aortic aneurysms, arterial venous fistulas, false aneurysms,ureters, and may be useful in dissection procedures, treatment oftrauma-injury of arteries, and to provide internal bypasses.

It is to be understood that the invention is not limited to the exactdetails of construction, operation, exact materials or embodiments shownand described, as obvious modifications and equivalents will be apparentto one skilled in the art. For example, the catheter of the apparatuscould be provided with three inflatable portions, two of which may beused to urge the prosthesis against the interior wall of the bodypassageway and remove or reduce kinks, twists and/or folds in theprosthesis. Accordingly, the invention is therefore to be limited onlyby the scope of the appended claims.

I claim:
 1. An apparatus for repairing a body passageway, comprising:acatheter having first and second ends, the first end of the catheterbeing insertable into the body passageway, a first inflatable portiondisposed on the catheter proximate the first end of the catheter, and asecond inflatable portion disposed on the catheter between the firstinflatable portion and the second end of the catheter; a prosthesishaving first and second ends; and a first means for securing theprosthesis to the body passageway, the first securing means beingassociated with the prosthesis proximate the first end of theprosthesis, and the first securing means and prosthesis being disposedupon the second inflatable portion of the catheter.
 2. The apparatus ofclaim 1, wherein the first and second inflatable portions are first andsecond inflatable balloons.
 3. The apparatus of claim 1, furtherincluding a second means for securing the prosthesis to the bodypassageway, the second securing means being disposed upon the firstinflatable portion.
 4. The apparatus of claim 3, wherein the first andsecond means for securing are first and second expandable tubular shapedmembers.